Biobank legislation in Belgium and Scientific research activities: threats, challenges and opportunities

The world of research is constantly evolving and creating new challenges in all areas, particularly in the field of biological and medical sciences. Thus, personalized medicine (targeted therapies and immunotherapies), "connected" health, the increasingly complex analysis of "big data", the increasingly sophisticated imaging techniques in histology and radiology, are opening multiple fields of investigation for researchers.


Progress in the life sciences cannot be achieved without the study of tissues, cells and samples of human origin. To this end, these human biospecimen samples must be kept, processed and listed in optimal conditions to be made available to researchers (or end-users). This is the work done by biobanks. Biobanks are thus the essential elements for the development of the translational research by providing exclusively access to samples for research without human applications, and compliance with ethical and legal requirements. These materials serve among other things to identify the causes and mechanisms of action of diseases, participate in the development of new diagnostic, prognostic and predictive tests, allow the development of new drugs, improve the treatment of patients, identify patients predisposed to a disease, or predict a patient's response to a drug.


The Royal Decree on Biobanks is now published and has important consequences for the organization, functioning and activities of biobanks. There is no more Science without biobanks and their related activities! In addition to the rules it imposes, it also brings into force the amendments made in 2013, 2014 and 2016 to the law of 19 December 2008 on the human biospecimen samples. New rules are then applicable, particularly with regard to the conditions for sampling the human materials and its traceability, the opinions to be solicited from the ethics committees, the notification of the biobanks, the reports to be sent to the FAMHP, the operating conditions of the biobanks... The new biobanking legislation has consequences for everybody involved in collecting and using human bodily materials for use in scientific research.


Nevertheless, there are opportunities behind the rules that will allow biobanks and end-users to expand and sustain their activities. The presentation will illustrate the actions that BWB (Biothèque Wallonie Bruxelles) is putting in place to help and support its partners and end-users with regard to this new legislation in their daily life.


Laurent Dollé


BWB (Biothèque Wallonie Bruxelles) Department of Pathology Erasme Hospital, Day Hospital (Road 950), Lennik Road 808, ULB, 1070 Brussel, Belgium

Presenting author

Laurent Dollé, Managing Director, BWB (Biobanking Wallonia Brussels)
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